MAUDE Adverse Event Report: AV-TEMECULA-CT MITRACLIP SYSTEM STEERABLE GUIDE CATHETER

Catalog Number SGC0301

Device Problem Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/23/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The customer reported the device was discarded.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

This is filed to report the displaced pacemaker lead due to interaction with the steerable guide catheter.It was reported that on (b)(6) 2018 this was a mitraclip procedure to treat grade 4 degenerative mitral regurgitation (mr).Two mitraclips were successfully implanted reducing mr to grade 3.The steerable guide catheter was removed without resistance but it was noted to have interacted with the permanent pacemaker pacing lead that was in the right atrium.It was not known at that time that the lead had been displaced.On (b)(6) 2018 a procedure was performed to replace the lead that was displaced.The patient tolerated the procedure.There was no abnormal heart rhythm due to the lead displacement.No additional information was provided.

Manufacturer Narrative

(b)(4).Weight has been estimated.The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Review of the complaint history identified no similar incidents reported from this lot.The reported device damaged by another (steerable guide catheter displaced pacing lead) appears to be due to a combination of the patient pathology (patient had pacemaker pacing lead in the right atrium) and user technique/ procedural conditions.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: MITRACLIP SYSTEM STEERABLE GUIDE CATHETER
• Type of Device: STEERABLE GUIDE CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 7778632
• MDR Text Key: 116954198
• Report Number: 2024168-2018-06218
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/03/2019
• Device Catalogue Number: SGC0301
• Device Lot Number: 80403U114
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TWO IMPLANTED MITRACLIPS; TWO IMPLANTED MITRACLIPS
• Patient Outcome(s): Required Intervention
• Patient Age: 92 YR
• Patient Weight: 62